NCT01413386终止不适用
A Randomized Clinical Trial Comparing Patency and Safety of the Paclitaxel Eluting Covered Metallic Biliary Stent (Niti-S Mira-Cover II Biliary Stent) to the Common Covered Metallic Biliary Stent.
Jong Taek, Lee5 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2011年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 74
- 试验地点
- 5
- 主要终点
- Accumulative Patency Rate
研究概览
简要总结
Paclitaxel covered metal biliary stent is non-inferior to common covered metal biliary stent in their patency rate and safety at the 6 months after stenting.
详细描述
Paclitaxel covered metal biliary stent (Niti-S Mira-Cover II Biliary Stent) is non-inferior to common covered metal biliary stent (Niti-S Biliary Stent_ComVi type)in their patency rate and safety at the 6 months after stenting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who submitted a written informed consent for the this trial, and 18 ~ 90 years old
- •Patient who have pancreatic cancer and/or biliary cancer with mid or distal CBD invasion
- •Patient who is inoperable and/or unresectable cases of malignant pancreatic stenosis
- •Patient who is attempting of endoscopic biliary metallic stenting (by ERBD) firstly
- •Patient who have life expectancy at least longer than 3 months (Karnofsky score >60%)
排除标准
- •Patient who previously had surgical biliary drainage
- •Patient who carrying bleeding disorder
- •Patient who have combined Hilar and/or intra-hepatic duct cancer
- •Patient who is improper to endoscopic treatment
结局指标
主要结局
Accumulative Patency Rate
时间窗: 6 months
次要结局
- Possibility of Other Treatment after Obstruction(6 months)
- Accumulative Survival Rate(6 months)
- Stent migration rate(6 months)
研究者
Jong Taek, Lee
Taewoong Medical Co., Ltd.
Taewoong Medical Co., Ltd.
研究点 (5)
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